Dry microorganism barrier tester and dry microorganism barrier testing method for breathable packaging material

Abstract

The invention relates to a dry microorganism barrier tester and a dry microorganism barrier testing method for a breathable packaging material, and belongs to the field of medical instrument inspection experimental equipment. The tester comprises a bottom plate, a temperature control box, a dry powder subpackaging module, a culture bottle carrier, a first linear module, a second linear module, a third linear module and a bottle cap tightening device, wherein the culture bottle carrier is used for containing a disposable sterile culture bottle; and the dry powder subpackaging module is used for quantitatively subpackaging contaminated quartz dry powder. Compared with manual operation, the dry microorganism barrier tester has the advantages that the upper surface of a to-be-tested packaging material is more uniformly covered with the contaminated quartz dry powder; stable movement of the culture bottle carrier is realized by utilizing the first linear module, the problem of uncontrollable bottle body shaking caused by manual operation is solved, the risk of pollution is reduced, and the detection result is more accurate; and by setting a quantitative hole with a fixed volume and a filter screen structure, rapid quantification and uniform coverage of the contaminated quartz dry powder are realized, and the risk of outward sprinkling of the contaminated quartz dry powder due to manual filling is avoided.

Description

technical field [0001] The invention relates to a dry microbial barrier tester and a test method for breathable packaging materials, and belongs to the field of medical device inspection and experiment equipment. Background technique [0002] According to the requirements of YY / T 0681.14-2018 "Test Methods for Sterile Medical Device Packaging Part 14: Wet and Dry Microbial Barrier Tests for Breathable Packaging Materials", the packaging of sterilized items with sterilization labels needs to undergo microbial barrier tests, especially It is a breathable packaging material for sterile medical devices. The standard test methods include wet microbial barrier test and dry microbial barrier test. The specific steps of the dry microbial barrier test are as follows: by cooling the air in the culture bottle sealed with the packaging material to be tested, the air is sucked through The packaging material to be tested enters the culture bottle, thereby generating an air flow. Before c...

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Problems solved by technology

There is no relevant detection test instrument in the prior art, and the following problems exist in the prior art: (1) the test operation process is mainly manual operation, which is easy to cause contamination of the test equipment by miscellaneous bacteria, resulting in inaccurate test results; (2) the test During the process, it is necessary to ensure that the test sample is not shaken as much as possible, and the shaking degree of the manual sample is uncontrollable, which affects the determination of the final number of colonies; The existing technology is mainly manually poured on the surface of the packaging material to be tested, and the dry powder of the contaminated quartz cannot evenly cover the surface of the packaging material to be tested, resulting in low test efficiency and poor consistency of test results

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